BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 2261484 · Received September 20, 2011

    Report

    Report Number
    2953749-2011-00122
    Event Type
    Other
    Date Received
    September 20, 2011
    Date of Event
    September 19, 2011
    Report Date
    September 21, 2011
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALIGNERS ARE NOT BEING EVALUATED. METHOD: AS THE PRODUCT PERFORMED IN ACCORDANCE TO SPECIFICATIONS. CONCLUSION: AND THE DEVICE WAS USED IN ACCORDANCE WITH LABELED INDICATIONS. THE PT'S SYMPTOMS OF LOWER JAW PAIN ARE NOT CONSIDERED SERIOUS IN NATURE AND IS A KNOWN SYMPTOM OF ORTHODONTIC TREATMENTS. THE PAIN HAS NOW BECOME CHRONIC, AND THE PT IS TAKING MEDICATIONS. THE ROOT CAUSE OF THE PT'S SYMPTOMS HAS NOT BEEN IDENTIFIED. IT IS THOUGHT THAT THE PT'S USE OF ANTIBIOTICS FOR PROLONGED PERIODS, MAY HAVE CAUSED "CANDIDA" (YEAST-LIKE MITOSPORIC SACCHAROMYCETALES FUNGI, COMMONLY PART OF THE NORMAL FLORA OF THE SKIN, MOUTH, AND CAN CAUSE A VARIETY OF INFECTIONS ) INSIDE THE PT'S MOUTH. THE SYMPTOMS MAY BE RELATED TO "CANDIDA", BUT THE TREATING DOCTOR DID NOT THINK THIS ISSUE WAS DUE TO THE USE OF THE ALIGNERS, SINCE THE SYMPTOMS PERSISTED EVEN AFTER STOPPING THE INVISALIGN TREATMENT. NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THE FACT THAT THE INVISALIGN PRODUCT CAUSE OR CONTRIBUTED TO THE PT CURRENT CONDITION. SINCE THE INVISALIGN PRODUCT WAS BEING USED AT THE TIME OF THE REPORTED SYMPTOMS AND SINCE THE SYMPTOMS REMAINS, AN MDR IS BEING FILED.

    Description of Event or Problem · 1

    ON (B)(4) 2011, DR REPORTED THAT THE PT STOPPED THE INVISALIGN TREATMENT SOMETIME IN (B)(6) 2010 AND SHE HAS BEEN EXPERIENCING LOWER JAW PAIN ON THE PREMOLAR SEGMENT, WHICH HAS BECOME A CHRONIC PAIN. THE PT HAD EXPERIENCED THIS SYMPTOM DURING HER ORTHODONTIC TREATMENT (UNDER DR. (B)(6)). DR. (B)(6) HAS REFERRED THE PT TO A "PAIN SPECIALIST" WHICH IS CURRENTLY CONTINUING TO EVALUATED THE PT AND WHOM HAS PRESCRIBED THE PT MEDICATION TO STABILIZE THE PT'S SYMPTOMS. THE ROOT CAUSE HAS OF THE PT'S SYMPTOMS NOT BEEN IDENTIFIED. WHEN DR. (B)(6) WAS TREATING THE PT HE DETERMINED THAT HER SYMPTOMS WERE NOT DUE TO THE ALIGNERS BUT TO THE MULTIPLE ANTIBIOTICS THAT THE PT WAS TAKING AT THE TIME OF TREATMENT. DR. (B)(6) THOUGHT THAT THE USE OF THE ALIGNERS COULD HAVE EXACERBATING THE PT'S "CANDIDIASIS" SYMPTOMS AND THAT WAS THE REASON DR. (B)(6) MADE HER STOP THE TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC. INVISALIGN FULL 69601630

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other